On May 7, 2019 Premier Inc. (NASDAQ: PINC) reported financial results for the fiscal 2019 third quarter ended March 31, 2019 (Press release, Premier, MAY 7, 2019, View Source [SID1234535849]).

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The company adopted new revenue recognition standard ASC 606 on July 1, 2018, in conjunction with the beginning of fiscal 2019, using the modified retrospective approach and did not restate prior periods. Therefore, fiscal 2019 results of operations under the new revenue standard ASC 606 are compared with fiscal 2018 results under the previous revenue standard ASC 605 in the body of this press release, and the comparisons are not necessarily meaningful. However, solely for informational purposes, current period results under the previous standard are included in the tables at the back of this press release.

Q3 2019 Highlights:

GAAP net revenue was $422.9 million, compared with $425.3 million a year ago; Supply Chain Services segment revenue was $330.2 million, compared with $330.7 million a year ago; and Performance Services segment revenue was $92.6 million, compared with $94.6 million a year ago.
GAAP net income was $73.8 million, compared with $76.5 million a year ago, and diluted net income was $0.48 per share, compared with a loss of $1.93 per share a year ago.
Non-GAAP adjusted EBITDA* was $137.6 million, compared with $142.2 million a year ago.
Non-GAAP adjusted fully distributed net income* was $84.7 million, or $0.66 per diluted share, compared with $90.6 million, or $0.67 per diluted share a year ago.
Nine-month results demonstrate financial performance remains on track with existing guidance ranges for the full fiscal year, with net administrative fees up 4% from a year ago, supply chain services and performance services revenue up 1% and 3%, respectively, non-GAAP adjusted EBITDA up 6% and non-GAAP adjusted fully distributed earnings per share up 22%.
For full fiscal-year, Supply Chain Services revenue projected to perform near midpoint of existing range, Performance Services segment revenue near higher end of the range, non-GAAP adjusted EBITDA near lower end of the range, and non-GAAP adjusted fully distributed earnings per share near midpoint of the range.
Outlook raised for full fiscal-year non-GAAP free cash flow, which is now expected to exceed 55% of non-GAAP adjusted EBITDA for the full fiscal year.
On April 26, 2019, Premier’s board of directors authorized an additional $300.0 million for the potential repurchase of Class A stock, following the completion of the previous $250.0 million repurchase program during the fiscal third quarter.
* Descriptions of non-GAAP financial measures are provided in "Use and Definition of Non-GAAP Financial Measures," and reconciliations are provided in the tables at the end of this release.

"Our fiscal third-quarter results reflect the timing-related impact of revenue recognition under the new ASC 606 revenue standard, continuing headwinds in our products business, and, to a lesser extent, incremental investments in future growth opportunities that we believe will enhance our core capabilities across the supply chain, enterprise analytics and performance improvement businesses," said Susan DeVore, chief executive officer. "While our results are consistent with our expectation that the second half of our fiscal year would be less profitable than the first half, we remain on track to deliver full fiscal-year 2019 results within our previously disclosed guidance ranges.

"We are actively managing Premier’s portfolio, as underscored by our decision to exit the specialty pharmacy business, and focusing on our core capabilities to deliver best-in-class solutions for our member health systems and sustainable, long-term value creation for stockholders," DeVore continued. "The company’s flexible balance sheet and strong cash flow provide a solid foundation and support our balanced approach to pursuing both organic and external growth opportunities while returning capital to stockholders. The board’s decision to authorize a new $300.0 million stock repurchase program underscores its continued confidence in our strategy."

On May 7, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, reported two presentations at the 2019 American College of Mohs Surgery (ACMS) Annual Meeting held in Baltimore from May 2-5 (Press release, Castle Biosciences, MAY 7, 2019, View Source [SID1234535848]).

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Progress in the development of a prognostic gene expression profile test in cutaneous squamous cell carcinoma (cSCC) was highlighted in an oral presentation. The total number of deaths from cSCC, one of the most common cancers in the U.S., is approaching or surpassing that from melanoma. Many patients with cSCC will have a favorable prognosis, but 25-40% of high-risk subsets will experience metastasis or develop recurrences. Current cSCC staging systems are evolving but more accurate methods of risk prediction are needed to appropriately direct workup and treatment. The goal of this development program is to identify and validate a clinical test that improves upon existing clinicopathologic staging systems to identify patients who have a high risk for regional/distant metastasis and enable more informed clinical management decisions.

In an ongoing development study, primary cSCC specimens with associated clinical outcome data were accrued from 18 centers. The discovery phase of the program included determining genes identified for their expression in recurrent and non-recurrent tumors. Researchers successfully identified genes that exhibited significant differential expression in cSCC samples from patients who experienced a recurrence, including several specific to regional/distant metastasis. In an archival training cohort of 122 patients, gene expression data from 140 candidate genes were used to identify a preliminary gene set and predictive algorithm.

To assess the predictive value of this assay, Kaplan-Meier survival analysis was performed in an independent validation cohort of 107 patients. Results from the analysis support the predictive value of the test to identify two groups of patients with significantly different risk for regional/distant metastasis (p<0.0001). The positive predictive value of the test in this preliminary validation study was 60%, which compares favorably to the performance of current staging systems in this cohort.

Based on these preliminary validation results, an expanded validation program for the cSCC prognostic test is now underway, including additional archival studies and a prospective validation study.

"The continued progress toward validation of this prognostic test for cSCC demonstrates that improvements in risk identification based on tumor biology are feasible," said Sarah T. Arron, M.D., Ph.D., University of California San Francisco and the San Francisco VA Health System, an investigator in the study. "Clinical use of a validated prognostic test such as this could help inform clinical decisions on staging and adjuvant therapy, and improve upon currently used staging systems."

Second study presented at ACMS

A second study presented as a poster at ACMS highlighted results from a meta-analysis evaluating the performance of the DecisionDx-Melanoma gene expression profile test in four unique, independent patient cohorts.

Results from this meta-analysis with 1,479 patients from four independent cohorts confirm that the DecisionDx-Melanoma test is a significant, independent predictor of recurrence and metastasis in patients with Stage I-III melanoma. Patients identified as highest risk (Class 2B) by the DecisionDx-Melanoma test were 2.9 times more likely to experience recurrence than those identified as lowest risk (Class 1A, p<0.0001), independent of other clinicopathologic features. The meta-analysis, a statistical method considered to be among the highest level of evidence (Level 1A) for prognostic tests, supports the use of the DecisionDx-Melanoma gene expression profile test to inform patient management decisions.

About Cutaneous Squamous Cell Carcinoma

Cutaneous squamous cell carcinoma (cSCC), a non-melanoma skin cancer, is one of the most common cancers. Approximately 200,000 patients per year are diagnosed with cSCC with high-risk features. Most patients have a favorable prognosis, but a subset of patients will develop metastasis and up to 15,000 patients each year die from their disease. As current staging parameters have a low positive predictive value, many more patients are considered high risk than actually develop metastatic disease. Conversely, many patients who develop metastatic disease are misidentified as low risk. This may lead to over and undertreatment of a substantial number of cSCC patients. To address this clinical need, Castle Biosciences is developing a gene expression profile test designed to improve upon current staging systems and identify patients with cSCC at high risk for metastasis or recurrence, in order to enable more informed clinical decisions regarding adjuvant therapy and other management options.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multicenter studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in five prospective studies including more than 780 patients. The consistent high performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multicenter and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On May 7, 2019 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) ("Rocket"), a leading U.S.-based multi-platform clinical-stage gene therapy company, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket is scheduled to present on Wednesday, May 15, 2019, at 3:40p.m. Pacific Time at the Bank of America Merrill Lynch 2019 Healthcare Conference in Las Vegas, Nevada (Press release, Rocket Pharmaceuticals, MAY 7, 2019, View Source [SID1234535847]).

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Gaurav Shah, M.D. will also participate in a Gene Therapy Panel on Wednesday, May 15, 2019, at 4:20p.m. Pacific Time

A live audio webcast of the presentation will be available on the Investors section of the company’s website, www.rocketpharma.com. A replay of the presentation will be archived on the Rocket website following the conference.

On May 7, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) ("Adamis"), a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas including respiratory disease and allergy, reported that it will host an investor conference call on Thursday, May 9, 2019 at 2:00 pm Pacific Time to discuss its financial and operating results for the first quarter of 2019 as well as provide an update on business developments and activities (Press release, Adamis Pharmaceuticals, MAY 7, 2019, View Source [SID1234535846]). The company’s press release concerning its first quarter 2019 financial results will be available after 1:00 p.m. Pacific time on May 9, 2019, on its website at www.adamispharmaceuticals.com , and the company also expects to file its quarterly report on Form 10-Q for the first quarter ended March 31, 2019, on that date.

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Event: Adamis Pharmaceuticals First Quarter 2019 Conference Call

Date:Thursday, May 9, 2019

Time:2:00 pm PT (5:00 pm ET)

US Dial-in (Toll Free): 1-800-458-4148

TOLL/International Dial-in: 1-323-794-2597

Conference ID: 1311319

Dr. Dennis J. Carlo, President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during this quarter and certain target milestones and goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link – View Source Participants should access this webcast site 10 minutes before the start of the call. In addition, a telephone playback of the call will be available after approximately 5:00 pm PT on May 9, 2019. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 1311319.

On May 7, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, reported that it has appointed Steven B. Engle as its Chief Executive Officer, effective May 15, 2019 (Press release, CohBar, MAY 7, 2019, View Source [SID1234535845]). CohBar’s interim Chief Executive Officer Dr. Philippe Calais will continue to serve on the company’s Board, a position he has held since June 2018.

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"Steven is a highly accomplished healthcare executive, and we are very happy to have him leading the CohBar team at this important time in the company’s evolution," said Albion J. Fitzgerald, Chairman of the Board of Directors. "With our phase 1a/1b clinical trial of CB4211 in NASH and obesity, and our expanding pipeline of mitochondrial-derived peptides that hold great promise as a new class of novel therapeutics, we believe we are well positioned to become a leader in the development of therapeutics to treat a broad range of age-related diseases. We expect that Steven’s extensive experience in drug discovery, development and commercialization, together with his track record of executing value-creating strategic transactions, will be instrumental in leading the company toward achieving our corporate and clinical goals."

"On behalf of the Board, I would like to thank Philippe for his dedication, contributions and leadership during this transition. We look forward to his continued contributions as a valued member of our Board," Mr. Fitzgerald concluded.

"I am very pleased to be working with the CohBar Board, executive management and the broader team to realize the company’s vision to develop mitochondria based therapeutics that treat chronic diseases with underlying metabolic dysfunction," commented Mr. Engle. "This is an exciting time for CohBar, and I look forward to our advancing the company’s novel pipeline through value-creating milestones."

Steven Engle has over 20 years of executive leadership experience with public biotech companies developing breakthrough products in metabolic, autoimmune, oncologic and infectious disease areas. Before joining CohBar, Mr. Engle served for seven years as CEO of Averigon Consulting, an advisory firm to the life science industry, supporting companies through product partnering, regulatory planning, investor relations and executive management. Previously, he served for four years as Chairman and CEO of XOMA Corporation, a leader in therapeutic antibodies and antibody technologies. Prior to XOMA, Mr. Engle served for fourteen years as Chairman and CEO of La Jolla Pharmaceutical Company, which discovered the biology of B cell tolerance, developed the first B cell toleragen for lupus patients, and received an approvable letter from the FDA. Earlier, he also served as Vice President of Marketing for Cygnus, Inc., a drug delivery systems company, where he helped to gain FDA approval and to launch Nicotrol for smoking cessation.

Mr. Engle is Chairman of the Board of Prescient Therapeutics Ltd., a clinical stage oncology company, and also serves on the Boards of Author-it Software Corporation, and AROA Biosurgery Ltd. He is a former director of BIO, BayBio and BIOCOM, and served on the board of the Lupus Foundation of America. Mr. Engle holds M.S.E.E. and B.S.E.E. degrees from the University of Texas with a focus in biomedical engineering.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent, and announced the anticipated resumption of the clinical trial in May 2019. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.